BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL SOLANA SARS-COV-2 ASSAY (M313)

    MDR report key: 11698408 · Received April 20, 2021

    Report

    Report Number
    1000122536-2021-00032
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    January 31, 2021
    Report Date
    April 20, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    UDI-DI
    30014613339656
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONAL SUMMARY: TS HAS TRIED REACHING OUT TO CUSTOMER FOR ADDITIONAL INFORMATION. CUSTOMER HAS BEEN UNRESPONSIVE FOR UPDATE ON THE OUTCOME AND OFFERS FOR ADDITIONAL ASSISTANCE.

    Description of Event or Problem · 1

    FALSE POSITIVE: INVALIDS/ FALSE POSITIVE ON PATIENT SAMPLE AND CONTROLS. 3 INSTRUMENTS. NO INFORMATION ON TECHNIQUE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590784 QUIDEL SOLANA SARS-COV-2 ASSAY (M313) SOLANA SARS-COV-2 ASSAY QJR QUIDEL CORPORATION Coronavirus 110420 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1